Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 4: FDA: Digital IND Safety Reporting

Session Chair(s)

Ginny  Hussong

Ginny Hussong

Branch Chief, Data Standards, CBER

FDA, United States

This session will provide an FDA overview and update on the new FDA Digital IND Safety initiative, which will require industry to submit IND Safety Reports in ICH E2B format directly to FAERS, and no longer within an eCTD submission. Panelists will discuss the related binding guidance for industry and technical conformance guide, including which submission types are included in the requirement, steps FDA has taken to pilot and test the new submission process, and submission pathways sponsors may choose.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Evaluate the goals of the IND Safety Reporting initiative
  • Describe FDA’s approach to digital IND Safety Reporting
  • Identify how IND Safety Reporting will impact sponsors


Meredith K. Chuk, MD, MHS

FDA’s Implementation of Digital IND Safety

Meredith K. Chuk, MD, MHS

FDA, United States

Acting Associate Director for Safety, OOD, OND, CDER

Suranjan  De, MBA, MS

FAERS II Status Update for IND Safety

Suranjan De, MBA, MS

FDA, United States

Deputy Director, Regulatory Science, OSE, CDER

Vali  Tschirgi

Safety Reporting Portal Update

Vali Tschirgi

FDA, United States

Project Manager, CBER

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.